MAUDE Adverse Event Report: COVIDIEN ABRE VENOUS SELF-EXPANDING STENT SYSTEM; STENT, ILIAC VEIN

Model Number AB9U12100090

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use the abre self expanding stent to treat moderately calcified fibrous lesion in the mid right common iliac vein.Patient hydrated prior to implant procedure.Ivus used for stent measuring and sizing.The vessel had moderate tortuosity.The artery diameter was 18mm and lesion length was 100mm.There was no damage noted to packaging and no issues when removing the device from the hoop/tray.The device was prepped per the ifu with no issues.The lesion was pre-dilated with a 20mm pre-dilation device.The device did pass through a previously deployed stent.There was no resistance encountered when advancing the device.It was reported that the wrong diameter stent was placed into patient from right jugular access, stent intended to overlap a previously deployed 16mmx80mm abre in the cf/external iliac vein.The 12mmx100mm abre stent was deployed inside the 16x80 and was floating on the wire.A 20mmx40mm balloon was inserted to post dilate the 12x100 stent, the stent was still floating on the wire.A 20mmx120mm stent was then deployed inside the 12x100 and overlapping proximal and distal into common <(>&<)> external vein.The 20mmx120mm stent trapped the 12x100 and then both stents were post dilated to 20mmx40mm with a non medtronic high pressure balloon.No issues with deployment of abre stent.Ivus was inserted to confirm the smaller stent was trapped and all stents had vein wall apposition. venogram was preformed to confirm blood flow and then everything was removed from the body to complete the case.Patient was not harmed and was moved to cvop.No patient injury.

• Brand Name: ABRE VENOUS SELF-EXPANDING STENT SYSTEM
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13008772
• MDR Text Key: 285840772
• Report Number: 2183870-2021-00456
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00643169796249
• UDI-Public: 00643169796249
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2023
• Device Model Number: AB9U12100090
• Device Catalogue Number: AB9U12100090
• Device Lot Number: B120748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/15/2021
• Date Device Manufactured: 11/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male